Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers; Guidance for Industry; Availability, 35779-35781 [2016-13166]
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mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
protocol amendment to an existing IND
by the sponsor of the existing IND); and
(3) expanded access for widespread
treatment use through a treatment IND
or treatment protocol (designed for use
in larger patient populations). The
regulations are intended to facilitate,
when appropriate, the availability of
investigational new drugs outside of a
clinical investigation or approved drugs
where availability is limited by a risk
evaluation and mitigation strategy
(REMS) to patients with serious or
immediately life-threatening diseases or
conditions who lack other therapeutic
options.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of a guidance for industry
entitled ‘‘Charging for Investigational
Drugs Under an IND—Questions and
Answers,’’ which provides information
about the implementation of FDA’s
regulation on charging for
investigational drugs under an IND,
including investigational drugs made
available for expanded access use.
(FDA’s guidance documents are
available at https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
FDA has verified the Web site addresses
throughout this document, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.)
Additionally, in this issue of the
Federal Register, FDA is announcing
the availability of a guidance for
industry entitled ‘‘Individual Patient
Expanded Access Applications: Form
FDA 3926.’’ The guidance describes
Form FDA 3926 (Individual Patient
Expanded Access—Investigational New
Drug Application (IND)), which is
available for licensed physicians to use
for expanded access requests for
individual patient INDs as a streamlined
alternative to Form FDA 1571
(Investigational New Drug Application
(IND)), and describes the process for
submitting expanded access requests for
individual patient expanded access
INDs.
One of FDA’s major goals in
promulgating the expanded access
regulations was to make expanded
access a more transparent process by
increasing awareness and knowledge
about expanded access and the
procedures for obtaining investigational
drugs for treatment use. Since the
expanded access regulations went into
effect in 2009, FDA has received a
number of questions concerning
implementation of the regulations.
Consistent with the goal of making
expanded access processes more
transparent, FDA is providing guidance
VerDate Sep<11>2014
21:20 Jun 02, 2016
Jkt 238001
in a question and answer format to
address questions about how FDA is
implementing its expanded access
regulations, including questions about
when it is appropriate to request
expanded access under each of the three
expanded access categories, the types
and content of expanded access
submissions, IRB review of individual
patient expanded access, and the onset
and duration of expanded access use.
In the Federal Register of May 9, 2013
(78 FR 27115), FDA announced the
availability of the draft guidance
entitled ‘‘Expanded Access to
Investigational Drugs for Treatment
Use—Questions & Answers.’’ FDA
received several comments on the draft
guidance, and those comments were
considered as the guidance was
finalized. Based on public comments, in
addition to editorial changes made
primarily for clarification, the final
guidance includes significant
clarification on the types of expanded
access and when each type should be
used.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on expanded access to
investigational drugs for treatment use.
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 312 have been approved
under OMB control number 0910–0014,
and the collection of information
resulting from the submission of Form
FDA 3926 has been approved under
OMB control number 0910–0814.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/RegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
PO 00000
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Fmt 4703
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35779
Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–13165 Filed 6–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0447]
Charging for Investigational Drugs
Under an Investigational New Drug
Application—Questions and Answers;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled ‘‘Charging
for Investigational Drugs Under an
IND—Questions and Answers.’’ The
guidance provides information for
industry, researchers, physicians,
institutional review boards (IRBs), and
patients about the implementation of
FDA’s regulation on charging for
investigational drugs under an
investigational new drug application
(IND) for the purpose of either clinical
trials or expanded access for treatment
use. FDA received a number of
questions concerning its
implementation of the charging
regulation. FDA is providing guidance
in a question and answer format to
address the most frequently asked
questions about charging for
investigational drugs under an IND.
This guidance finalizes the draft
guidance issued in May 2013.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
E:\FR\FM\03JNN1.SGM
03JNN1
35780
Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–D–0447 for ‘‘Charging for
Investigational Drugs Under an IND—
Questions and Answers; Guidance for
Industry; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
VerDate Sep<11>2014
21:20 Jun 02, 2016
Jkt 238001
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
Submit written requests for single
copies of this guidance to the Division
of Drug Information, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Ebla
Ali Ibrahim, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6302, Silver Spring,
MD 20993, 301–796–3691; or Stephen
Ripley, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Charging for Investigational Drugs
Under an IND—Questions and
Answers.’’ In 2009, FDA amended the
regulation concerning charging for
investigational new drugs under an IND
(74 FR 40872, August 13, 2009). The
new regulation, which went into effect
on October 13, 2009, removed paragraph
(d) of § 312.7 (21 CFR 312.7(d)) and
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
replaced it with new § 312.8. The
guidance clarifies the circumstances in
which charging for an investigational
drug under an IND for the purpose of
clinical trials is appropriate and also
sets forth criteria for charging for an
investigational drug for the three types
of expanded access for treatment use
described in 21 CFR part 312, subpart I,
and clarifies what costs can be
recovered for an investigational drug.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of a guidance for industry
entitled ‘‘Expanded Access to
Investigational Drugs for Treatment
Use—Questions and Answers,’’ which
provides answers to questions
concerning the implementation of
FDA’s regulations on expanded access
to investigational drugs for treatment
use (part 312, subpart I). (FDA’s
guidance documents are available at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm. FDA has
verified the Web site addresses
throughout this document, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.)
Additionally, in this issue of the
Federal Register, FDA is announcing
the availability of a guidance for
industry entitled ‘‘Individual Patient
Expanded Access Applications: Form
FDA 3926.’’ That guidance describes
Form FDA 3926 (Individual Patient
Expanded Access—Investigational New
Drug Application (IND)), which is
available for licensed physicians to use
for expanded access requests for
individual patient INDs as a streamlined
alternative to Form FDA 1571 (IND),
and describes the process for submitting
expanded access requests for individual
patient INDs.
Since § 312.8 has been in effect, FDA
has received numerous questions about
its implementation of the charging
regulation. Consistent with the goal of
clarifying the requirements for charging
for an investigational drug and the types
of costs that can be recovered, FDA is
providing guidance in a question and
answer format, addressing the most
frequently asked questions and answers
about charging for an investigational
drug under an IND.
In the Federal Register of May 9, 2013
(78 FR 27116), FDA announced the
availability of the draft guidance
entitled ‘‘Charging for Investigational
Drugs Under an IND—Qs & As.’’ FDA
received several comments on the draft
guidance, and those comments were
considered as the guidance was
finalized. Based on public comments, in
addition to editorial changes primarily
E:\FR\FM\03JNN1.SGM
03JNN1
Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Notices
for clarification, the major changes
made to the guidance include adding
clarification about charging for certain
administrative costs in individual
patient expanded access INDs and
protocols, and the timing for submitting
a request to FDA to reauthorize
charging.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on charging for
investigational drugs under an IND. It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR 312.8 and 312.320 have been
approved under OMB control number
0910–0014.
III. Electronic Access
Persons with access to the Internet
may obtain the document at https://www.
fda.gov/RegulatoryInformation/
Guidances/default.htm, https://www.fda.
gov/BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, or https://
www.regulations.gov.
Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–13166 Filed 6–2–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK3G9T082PROD with NOTICES
[Docket No. FDA–2016–D–1255]
E18 Genomic Sampling and
Management of Genomic Data;
International Council for
Harmonisation; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
SUMMARY:
VerDate Sep<11>2014
21:20 Jun 02, 2016
Jkt 238001
guidance entitled ‘‘E18 Genomic
Sampling and Management of Genomic
Data.’’ The draft guidance was prepared
under the auspices of the International
Council for Harmonisation (ICH),
formerly the International Conference
on Harmonisation. The draft guidance
pertains to genomic sampling and to the
management of genomic data in clinical
studies. The focus of this draft guidance
is on the general principles of
collecting, processing, transporting,
storing, and disposing of genomic
samples or data. The technical aspects
of genomic sampling and research are
also discussed when appropriate,
recognizing the rapidly evolving
technological advances in these areas.
The draft guidance is intended to
provide harmonized principles of
genomic sampling and of managing
genomic data in clinical studies.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by August 2, 2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
35781
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–1255 for ‘‘E18 Genomic
Sampling and Management of Genomic
Data.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
E:\FR\FM\03JNN1.SGM
03JNN1
]]>Agencies
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Notices]
[Pages 35779-35781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13166]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-0447]
Charging for Investigational Drugs Under an Investigational New
Drug Application--Questions and Answers; Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a guidance for industry entitled ``Charging for
Investigational Drugs Under an IND--Questions and Answers.'' The
guidance provides information for industry, researchers, physicians,
institutional review boards (IRBs), and patients about the
implementation of FDA's regulation on charging for investigational
drugs under an investigational new drug application (IND) for the
purpose of either clinical trials or expanded access for treatment use.
FDA received a number of questions concerning its implementation of the
charging regulation. FDA is providing guidance in a question and answer
format to address the most frequently asked questions about charging
for investigational drugs under an IND. This guidance finalizes the
draft guidance issued in May 2013.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or
[[Page 35780]]
anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-D-0447 for ``Charging for Investigational Drugs Under an IND--
Questions and Answers; Guidance for Industry; Availability.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Ebla Ali Ibrahim, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301-796-
3691; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Charging for Investigational Drugs Under an IND--Questions
and Answers.'' In 2009, FDA amended the regulation concerning charging
for investigational new drugs under an IND (74 FR 40872, August 13,
2009). The new regulation, which went into effect on October 13, 2009,
removed paragraph (d) of Sec. 312.7 (21 CFR 312.7(d)) and replaced it
with new Sec. 312.8. The guidance clarifies the circumstances in which
charging for an investigational drug under an IND for the purpose of
clinical trials is appropriate and also sets forth criteria for
charging for an investigational drug for the three types of expanded
access for treatment use described in 21 CFR part 312, subpart I, and
clarifies what costs can be recovered for an investigational drug.
Elsewhere in this issue of the Federal Register, FDA is announcing
the availability of a guidance for industry entitled ``Expanded Access
to Investigational Drugs for Treatment Use--Questions and Answers,''
which provides answers to questions concerning the implementation of
FDA's regulations on expanded access to investigational drugs for
treatment use (part 312, subpart I). (FDA's guidance documents are
available at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. FDA has
verified the Web site addresses throughout this document, as of the
date this document publishes in the Federal Register, but Web sites are
subject to change over time.)
Additionally, in this issue of the Federal Register, FDA is
announcing the availability of a guidance for industry entitled
``Individual Patient Expanded Access Applications: Form FDA 3926.''
That guidance describes Form FDA 3926 (Individual Patient Expanded
Access--Investigational New Drug Application (IND)), which is available
for licensed physicians to use for expanded access requests for
individual patient INDs as a streamlined alternative to Form FDA 1571
(IND), and describes the process for submitting expanded access
requests for individual patient INDs.
Since Sec. 312.8 has been in effect, FDA has received numerous
questions about its implementation of the charging regulation.
Consistent with the goal of clarifying the requirements for charging
for an investigational drug and the types of costs that can be
recovered, FDA is providing guidance in a question and answer format,
addressing the most frequently asked questions and answers about
charging for an investigational drug under an IND.
In the Federal Register of May 9, 2013 (78 FR 27116), FDA announced
the availability of the draft guidance entitled ``Charging for
Investigational Drugs Under an IND--Qs & As.'' FDA received several
comments on the draft guidance, and those comments were considered as
the guidance was finalized. Based on public comments, in addition to
editorial changes primarily
[[Page 35781]]
for clarification, the major changes made to the guidance include
adding clarification about charging for certain administrative costs in
individual patient expanded access INDs and protocols, and the timing
for submitting a request to FDA to reauthorize charging.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on charging for investigational drugs under an
IND. It does not establish any rights for any person and is not binding
on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 312.8 and 312.320 have been
approved under OMB control number 0910-0014.
III. Electronic Access
Persons with access to the Internet may obtain the document at
https://www.fda.gov/RegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.
Dated: May 31, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13166 Filed 6-2-16; 8:45 am]
BILLING CODE 4164-01-P
